Percutaneous device and method for treating urinary stress incontinence in women using a sub-urethral tape

ABSTRACT

A device for treating urinary stress incontinence in women includes a flexible and elongate mechanism including a tape for supporting a urethra and a flat protective sheath enveloping the tape; and a puncturing needle with an active distal end and a proximal end connected to a first end of the flexible and elongate mechanism, wherein the proximal end of the puncturing needle is connected to a first end of the flexible and elongate mechanism by an intermediate traction element, a second end of the flexible and elongate mechanism being free. A method for treating urinary stress incontinence in a woman suffering from urinary stress incontinence is also provided including (a) forming an opening in an anterior vaginal wall; (b) creating, from two small suprapubic incisions formed in the abdominal wall, a right track and a left track from the abdominal skin to the opening formed in the anterior vaginal wall; (c) using a needle and an intermediate traction element to follow one of the tracks and following the other track with at least a needle; (d) verifying by cystoscopy that the paths of the tracks are outside the bladder and the urethra; (e) using a support tape surrounded by a plastic sheath to follow the tracks by passage under an inferior surface of the urethra; (f) adjusting a loop formed by the sheathed tape under the inferior surface of the urethra; (g) removing the sheath by pulling the sheath toward the outside of the woman&#39;s body through the small suprapubic incisions; and (h) leaving the tape implanted from the first to the second incision and around the urethra to support the urethra.

BACKGROUND OF THE INVENTION

[0001] 1. Field of Invention

[0002] The present invention relates to the problems of urinaryincontinence in women and more specifically to the problems of urinarystress incontinence. The invention relates more particularly to apercutaneous device for treating urinary stress incontinence in womenusing a sub-urethral tape.

[0003] 2. Description of Related Art

[0004] These problems are currently treated during surgicalinterventions under local, regional or general anesthetic and consist inimplanting a tape in such a way as to support the urethra withouttension.

[0005] Thanks to the regional or local anesthesia, the surgeon canimmediately check that continence has been restored, with theparticipation of the patient.

[0006] An intervention such as this is performed using an appropriatedevice including special instruments.

[0007] In particular, it is a known practice in treating urinaryincontinence to use a tape that can be implanted under the urethralcanal, and a sheath surrounding the tape, where the sheath is withdrawnfrom the tape after the latter has been implanted.

[0008] There is a known device for treating urinary stress incontinencein women, comprising:

[0009] a flexible and elongate urethra support means comprising a tapeand a protective sheath lying flat and enveloping the tape, and

[0010] a puncturing needle with an active distal end and a proximal endconnected to a first end of the flexible and elongate urethra supportmeans.

[0011] Thus, U.S. Pat. No. 5,899,909 discloses a treatment method and atreatment device for incontinence. The device described, which allows atape to be placed under the urethra, comprises two special needles.These are mounted in turn, by screw fastening, on a reusable steelinsertion tool made of a handle and of a threaded manipulator rod whichallows each of the needles to be manipulated in turn. Each needle isfixed to one of the ends of the tape-sheath assembly.

[0012] Each end of the tape-sheath assembly is fixed to a frustoconicalpart of one end of the corresponding needle, using a shrunk or bondedpolymer ring.

[0013] The tape is therefore implanted by introducing each of theneedles through a short incision in the anterior vaginal wall, theseincisions being one on each side of the central position of the urethra.

[0014] The needles implanted in turn using the manipulator rod, thentravel up around the bladder and the pubic bone and reemerge from thebody through incisions made in the abdominal wall in the suprapubicregion.

[0015] The two halves of the sheath which overlap at the middle of thetape are withdrawn by pulling on the ends that emerge from thesuprapubic incisions.

[0016] A device such as this requires the use of ancillaries of theinsertion handle and rigid intravesical catheter guide types especiallydesigned for this type of surgical intervention.

[0017] The known surgical intervention also has a disadvantage insofaras the needles are introduced into the anterior wall of the vagina toreemerge in the suprapubic region. This bottom-upward path cannot becontrolled precisely for going around the base of the bladder. Vesicalperforations are far from uncommon. They need to be recognizedpreoperatively through the use of two cystoscopies and entail repeatingthe maneuvers under more difficult conditions.

[0018] The two accessories (manipulator handle and rigid probe guide)must therefore be available to the surgical team during eachintervention, having been previously washed, packaged and sterilizedprior to each use. In addition, this lateral passage with respect to thebladder, with a vaginal point of entry runs the risk that the point ofthe needle will injure the iliac vessels in the retrocrural region.These vascular lesions have been observed and have led to fatalities.

[0019] Another drawback of the known device lies in the difficulty ofrepeating the intervention, using the same device, when cystoscopyreveals that the sheath-tape assembly has taken the wrong course.Retreat may prove difficult and tricky for the sheath, and especiallyfor the bulky needles.

[0020] The sheath-tape assembly has therefore to be cut and the devicecan no longer be used to take a different path. It also carries the riskof no longer being sterile as it may have been contaminated during theseadditional maneuvers.

[0021] Thus no percutaneous treatment exists for female urinary stressincontinence which uses a tape which can lead to the devices andtechnique of the present invention.

SUMMARY OF THE INVENTION

[0022] The present invention provides a device for treating urinarystress incontinence in women comprising a flexible and elongatemechanism comprising a tape for supporting a urethra and a flatprotective sheath enveloping the tape; and a puncturing needle with anactive distal end and a proximal end connected to a first end of theflexible and elongate mechanism, wherein the proximal end of thepuncturing needle is connected to a first end of the flexible andelongate mechanism by an intermediate traction element, a second end ofthe flexible and elongate mechanism being free.

[0023] A method for treating urinary stress incontinence in a womansuffering from urinary stress incontinence is also provided by thepresent invention comprising (a) forming an opening in an anteriorvaginal wall; (b) creating, from two small suprapubic incisions formedin the abdominal wall, a right track and a left track from the abdominalskin to the opening formed in the anterior vaginal wall; (c) using aneedle and an intermediate traction element to follow one of the tracksand following the other track with at least a needle; (d) verifying bycystoscopy that the paths of the tracks are outside the bladder and theurethra; (e) using a support tape surrounded by a plastic sheath tofollow the tracks by passage under an inferior surface of the urethra;(f) adjusting a loop formed by the sheathed tape under the inferiorsurface of the urethra; (g) removing the sheath by pulling the sheathtoward the outside of the woman's body through the small suprapubicincisions; and (h) leaving the tape implanted from the first to thesecond incision and around the urethra to support the urethra.

[0024] The object of the present invention is to overcome the drawbacksof the prior art so as to obtain a different operative technique whichis easier, quicker and safer (as far as the bladder and vessels areconcerned). The risk of vascular lesion is minimised because of theorientation and the given direction of the needle from the start of theprocedure. The risk of vesical puncture is small even in the case ofprevious interventions in this regard, as is particularly frequent inthis type of pathology. Using the device and operating method of theinvention, the percutaneous route is used to form top-to-bottom tracksusing the needle, i.e., penetrating via abdominal cutaneousmini-incisions to exit via a previously formed vaginal opening.Detachment of the vagina allows the index finger of the surgeon to beinsinuated up to the lower rim of the pubis and thus enables the trackof the needle to be precisely directed.

[0025] The device of the invention enables tracks to be made from top tobottom on both sides of the abdomen and enables the absence of vesicalpuncturing to be confirmed by cystoscopy before engaging the sheath-tapesystem. The present device makes it possible to employ the techniquesthat will be described in detail later on in this description.

[0026] Another object of the present invention is to produce a devicefor treating urinary incontinence which can be reused easily if it isintroduced into the body in a non-optimum path, an eventuality which,according to the present invention, can occur only under exceptionalcircumstances if there is very strong adhesion between the bladder andthe pubis, generally as the result of earlier interventions.

[0027] According to an embodiment of the invention, the proximal end ofthe puncturing needle is connected to the first end of the flexiblemeans by virtue of an intermediate traction element, the second end ofthe flexible means being free or extended by an additional intermediatetraction element.

[0028] According to one embodiment of the device according to theinvention, the protective sheath completely envelopes the tape,including its first and second ends.

[0029] According to one embodiment of the invention, the sheath can besplit into two parts that can be separated by sliding them in twoopposite directions relative to the tape, the device comprising asplinable means between the two central and adjacent ends of the sheath.

[0030] According to another embodiment of the device according to theinvention, the device comprises a filament arranged roughly at rightangles to the longitudinal axis of the sheath, configured to cut thesheath when traction is exerted on the filament.

[0031] According to one embodiment of the device according to theinvention, the sheath is made of a fluoropolymer-based heat-shrinkablematerial.

[0032] According to one embodiment of the device according to theinvention, the tape is formed from a macroporous knitted material.

[0033] According to one embodiment of the invention, the tape in itscentral region has resorbable hydrophilic film reducing the risk ofadhesion to or the risk of erosion of the urethra.

[0034] According to one embodiment of the device according to theinvention, the puncturing needle has a curved part continuously adjacentto a roughly straight part ending in its proximal end.

[0035] According to one embodiment of the invention, the intermediatetraction element is a traction lace.

[0036] According to one embodiment, the device according to theinvention comprises an end piece onto which the sheath is heat shrunkand to which the traction lace attaches.

[0037] According to one embodiment according to the invention, thetraction lace has a length roughly equal to the length of the flexiblemeans.

[0038] According to a preferred embodiment of the device according tothe invention, the intermediate traction element is tubular.

[0039] According to one embodiment of the device according to theinvention, the intermediate traction element and the puncturing needleare assembled by screwing.

[0040] According to one embodiment of the device according to theinvention, the traction element consists of two parts of roughly thesame length, placed end to end and joined together removably, forexample by screwing, using a coupling.

[0041] According to one embodiment of the device according to theinvention, the puncturing needle with an active distal end and aproximal end attached to a flexible and elongate means is the onlypuncturing needle.

BRIEF DESCRIPTION OF THE DRAWINGS

[0042] Other features and advantages of the invention will becomeapparent from the detailed non-limiting description given hereinafterwith reference to the appended drawings, in which:

[0043]FIG. 1 depicts a view in section of the flexible means of thedevice according to the invention;

[0044]FIG. 2 depicts a view from above, with partial cutaway, of theflexible means shown in FIG. 1;

[0045]FIG. 3 depicts, in part, another exemplary embodiment of theflexible means of FIG. 2;

[0046]FIG. 4 depicts a partial view of a device according to theinvention;

[0047]FIGS. 5 and 6 depict details of FIG. 4;

[0048]FIGS. 7 and 8 depict another embodiment of the flexible means ofthe device according to the invention;

[0049]FIG. 9 depicts a partial view of another embodiment of the deviceaccording to the invention;

[0050]FIGS. 10, 11a, 11 b and 11 c depict details of the device depictedin FIG. 9;

[0051] FIGS. 12 to 19 diagrammatically depict the surgical methodemployed using the device according to the invention; and

[0052]FIGS. 20 and 21 diagrammatically depict the position of the deviceaccording to the invention in the body of a patient.

DETAILED DESCRIPTION OF PREFERRED EMBODIMENTS

[0053] The device depicted in FIGS. 1, 2, 3 and 4 comprises an elongateflexible means 1 generally comprising a composite band.

[0054] The flexible means 1 is shown only in part and not in its entirelength. It generally has a flattened and elongate shape.

[0055] The first end 1 a of the flexible means 1 can be connected to anintermediate traction element 2 (cf. FIG. 4) and the second end 1 b isfree or extended by an additional intermediate traction element (notdepicted).

[0056] The device according to the invention also comprises a puncturingneedle 3, for example made of stainless steel, connected to theintermediate traction element.

[0057] The flexible means 1 comprises a protective sheath 5 lying flatand enveloping a tape 6.

[0058] The single puncturing needle 3 has an active distal end 3 a and aproximal end 3 b connected to the first end 1 a of the flexible means 1.

[0059] The proximal end 3 b of the puncturing needle 3 is connected tothe first end 1 a by virtue of an intermediate traction element 2. Theproximal end 3 b is thus a non-puncturing end. The proximal end 3 b ofthe puncturing needle may have a substantially rectangular cross-sectionand may be flattened and/or ribbed. These features allow the surgeon togrip the needle and allows the needle to be oriented correctly.

[0060] The distal end 3 a is at the end of a curved part continuouslyadjacent to a roughly straight part, approximately between points 3 band 3 d, ending in the proximal end 3 b. The distal end 3 a may bepartially curved and preferably has a round cross-section. Distal end 3a may have a diameter of, for example, 0.5 mm. The roughly straight partmay be, for example, 20 to 25 cm in length and may, in embodiments, beribbed over at least a portion thereof.

[0061] The puncturing needle has, for example, a diameter of 3.5 mm inits curved part.

[0062] The proximal end 3 b is also equipped with an attachment meansallowing it to make a connection with the intermediate traction element.

[0063] The intermediate traction element is constituted by a hollow PVCtube with a diameter that is identical to, or closely similar indiameter to, that of the needle. The intermediate traction element ortubing may be approximately 40 to 50 cm long. Its distal end 19 andproximal end 20 comprise a male screw connecting piece. This screwconnecting piece is integrally fixed to the traction element by adhesionand/or screwing. The intermediate traction element may be colored, forexample blue, so that it can readily be located during cystoscopy in theevent of a vesical puncture.

[0064] The protective sheath 5 completely envelopes the tape 6,including its first end 6 a and its second end 6 b.

[0065] The sheath 5 is made, for example, of a fluoropolymer-basedheat-shrinkable material. The material of which the sheath 5 is made ischosen so that it is impervious, for example hermetically sealed, toisolate the tape 6 intended to be implanted in the body of the patientfrom contact with the skin and mucosa when following the implantationpaths through the body.

[0066] The sheath 5 may also exhibit properties of low coefficient offriction. These properties are therefore found both on the inside and onthe outside of the sheath 5, so as, on the one hand, to ensure goodseparation from the tape 6 and, on the other hand, to reduce thefriction inside the body of the patient when the flexible means 1 isbeing pulled.

[0067] The tape 6 advantageously has a width of between 6 and 14 mm,preferably between 10 and 12 mm and a length of between 30 and 50 cm,preferably around 40 cm.

[0068] The tape 6 is preferably formed from a macroporous knittedmaterial.

[0069] The macroporous knitted material comprises, for example, an openknit made of single stranded polypropylene of between 0.12 and 0.16millimeter thick and made up of two layers formed by two threaded guidebars each—one full guide and one empty guide—these two guides beingmoved symmetrically for open mesh according to the following chart:

[0070] bar I: 01-12-32

[0071] bar II: 32-21-01.

[0072] The tape 6 is cut to length in the warp direction of the knit.

[0073] The tape 6, with a width of for example 12 mm, has the followingproperties:

[0074] a breaking strength in the warp direction of 105N±20%,

[0075] an elongation at break in the warp direction of 92%±20%

[0076] an elongation of 36% under a force of 20N

[0077] an onset of curling with a force of 6N and an elongation of

[0078] 15%.

[0079] The expression “curling” is intended to mean the property wherebythe tape 6 rolls up on itself spontaneously about its longitudinal axisunder longitudinal tensile stress.

[0080] The tape 6 has attractive advantages and, in particular, lowemission of particles as it is stretched, and curling which occurs onlyunder high stress (6N). None of these aforementioned properties in anyway detracts from the porosity of the tape 6.

[0081] Tape 6 can have a resorbable hydrophilic film in its centralportion that reduces the risk of erosion or sclerosis of the urethra toa minimum. This central zone may be indicated by a colored marker.

[0082] In a variation, the tape may comprise other biologicallyacceptable materials.

[0083] The sheath 5 can preferably be split into two parts 51, 52 thatcan be separated by sliding them in two opposite directions with respectto the tape 6.

[0084] For this purpose, the device according to the invention has asplittable means 15, roughly at the middle of the sheath 5 and the twoends of which are secured to the corresponding and adjacent central ends5 c, 5 d of the sheath 5.

[0085] The material of the splittable means 15 is chosen from materialsof the thermoplastic type approved for surgical application.

[0086] The connection between, on the one hand, the central ends 5 c, 5d of the two parts 51 and 52 respectively and, on the other hand, thesplittable center 15, may be obtained by any means able to make thesheath 5 impervious. The same is true of the free end 5 b of the sheath5, which may be plugged and/or sealed.

[0087] The splittable means 15 comprises a flat slit 15 a passingthrough it from one longitudinal end to the other, for the free passageof the tape 6.

[0088] The splittable means 15 may be replaced in an embodiment depictedin figures 7 and 8, by an adhesive sleeve 16a joining the ends of thetwo splittable parts 51 and 52 of the sheath 5. This sleeve may beweakened, for example by a partial broken cut or a line of weakness inthe sheath 5. The adhesive sleeve 16 a made of a flexible material whichsticks firmly to the central ends 5 c, 5 d and has a precut tab 16 b tomake the sleeve 16 a easier to tear and therefore make the sheath 5easier to split into the two parts 51 and 52.

[0089] According to another embodiment of the device according to theinvention, the one-piece sheath 5 incorporates a filament 16 c arrangedroughly at right angles to the longitudinal axis of the sheath 5,configured to cut the sheath 5 when traction is exerted on the filament16 c. An example such as this is depicted, for example, in figure 3. Thefilament 16 c may be advantageously in color so that it can easily beidentified.

[0090] The sheath 5 can thus be split in the central zone 1 c of theflexible means 1 so release the tape 6 inside the body of the patient.

[0091] The intermediate traction element is, according to one embodimentof the invention, configured, for example, with a traction lace 2depicted in FIG. 4.

[0092] The device according to the invention may also comprise an endpiece 4 to which the sheath 5 is attached by heat-shrinking. The sheath5, more particularly its first end 5 a, may be heat shrunk in a sealedmanner onto the end piece 4.

[0093] As depicted in FIG. 2. the end piece 4 comprises anchoringnotches 4 a into which the heat-shrunk material of the sheath 5 engages.The end piece 4 is made, for example, of a piece of stainless steel orany other rigid material capable of contacting with intracorporaltissue.

[0094] Advantageously, the flexible means 1 comprises a knotting eye 4 b(cf. FIG. 4) arranged on the outside of the sheath 5. Knotting eye 4 bconsists, for example, of a closed loop and may, as appropriate, have apoint 4 c intended to pass through and catch on one end of the tractionlace 2 or any other intermediate traction element.

[0095] The knotting eye 4 b may, for example, be made integrally in theend piece 4. The latter may also have a roughly flattened and partiallyfrustoconical shape so as to achieve continuity between the variousthicknesses of the traction lace 2 and the flexible means 1. The latterhas a greater width than the traction lace 2. Thus a certain continuitybetween the dimensions of the traction lace 2 and of the flexible means1 is obtained. The traction lace may for example be made of aTeflon-coated material.

[0096]FIG. 4 diagrammatically depicts one exemplary embodiment of thedevice according to the invention.

[0097] The needle 3 comprises the proximal end 3 b onto which the firstend 2 a of the traction lace 2 is attached. The latter has, for example,at each of its ends 2 a and 2 b, a loop 2 c (cf. FIGS. 5 and 6respectively) obtained by ultrasonic welding, stitching or any othermeans.

[0098] One of these loops, 2 c, is mounted on the proximal end 3 b ofthe needle 3 while the other is mounted in the eye 4 b.

[0099] During the procedure, it is thus possible to attach the end 2 aof the traction lace 2 to the eye 4 b either using the point 4 c securedto the eye 4 b or simply by running it through the closed loop thatforms the eye 4 b.

[0100] The device according to the invention therefore, for example, hasa traction lace 2, the length of which is, for example, roughly equal tothe length of the flexible means 1, namely a length of between 30 and 60cm, for example 40 cm. Such dimensions or lengths of the traction lace 2make it possible, if reference is made to the operative procedure, toavoid engaging the flexible means 1 in the body before being sure thatthe path taken by the needle 3 and the traction lace 2 is optimum. Thelong available length of traction lace 2 for carrying out the operativeactions described thus makes it possible for another path to be takenthrough the body if need be, without having to manipulate the flexiblemeans 1.

[0101] By way of variation, it is possible to provide the second end 1 bof the flexible means 1 with an additional intermediate tractionelement, such as an additional lace like the one previously describedunder reference 2.

[0102] An additional traction lace 2 secured to the free end 1 b, whichmay also have an end piece 4 for this purpose, allows traction to beexerted in the opposite direction to its introduction on the flexiblemeans 1, and allows it to back-track along its path if it is penetratingincorrectly.

[0103] According to another embodiment of the device according to theinvention, depicted for example in FIG. 9, the intermediate tractionelement is a tubular element 20. The material of which the latter ismade may be, for example, PVC. Tubular element 20 may be, for example,2.5 mm in diameter.

[0104] The tubular element 20 is preferably semirigid, so that it can bescrewed onto a threaded end 3 c secured to the proximal end 3 b of theneedle 3. The other end of the tubular element 20 is connected, forexample by screwing, to the flexible means 1 comprising an end piece 30secured to the sheath 5, for example by heat shrinking. The end piece 30for this purpose has a complementary threaded part 30 a (see FIGS. 7 and8).

[0105] The flexible means 1, the tubular element 20 and the two parts 3a, 3 b of the puncturing needle 3 may thus be assembled removably byscrew fastening.

[0106] Other known removable means of connection or attachment may alsobe suitable in the context of the present invention.

[0107] The tubular element consists for example of a number of parts ofroughly the same length, for example 20 and 41, placed end to end andjoined together removably by screw fastening. This end-to-end joining isobtained using a coupling 40 depicted in FIGS. 10, 11a, 11 b and 11 c.

[0108] The coupling 40 is made up of two elements, namely an internalconnecting mandrel 42 and an external clamping bush 43.

[0109] At one end, the mandrel 42 has a threaded nipple 42 b engaged inthe tubular element part 41 and at the other end has a stud 42 a withteeth 42 c intended to be engaged in the tubular element part 20 asdepicted in FIGS. 11b and 11 c. The shape and dimensions of the teeth 42c tend to oppose separation of the tubular element part 20 from themandrel 42.

[0110] Each mandrel 42 is associated with a bush 43 engaged on thetubular element part 41 so as to clamp part of tubular element part 41between the threaded nipple 42 b and bush 43.

[0111] Bush 43 may also be provided on the anterior end with a tapping43 a which bites by screwing into the material of which the abutting endof part 20 is made.

[0112] To begin with, one end of part 41 of the tubular element isscrewed onto the nipple 42 b. Bush 43 is then attached to this end ofthe part 41, with the constituent material trapped between the screwthread of the nipple 42 b and the sleeve 43, the latter also clampingthe rest of the mandrel 42 except for the projecting stud 42 a.

[0113] The two tubular element parts 20 and 41 are assembled by engagingthe stud 42 a in one end of part 20 (FIG. 11b) and then by screwing theend of bush 43 onto the exterior periphery of part 20 (FIG. 11c). Theturning of bush 43 is depicted diagrammatically by the arrow R in FIG.11c. The mechanical connection between the tubular element part 20 andthe coupling 40 is thus improved.

[0114] The device according to the present invention makes it possibleto implement a method for treating women suffering from urinary stressincontinence. This method will be specified herein below and allows thetape 6 to be fitted in the patient's body.

[0115] The treatment method comprises:

[0116] a) forming an opening 103 a in the anterior vaginal wall 103;

[0117] b) making two small suprapubic incisions 106, 107;

[0118] c) using the puncturing needle 3 connected to an intermediatetraction means 2 or 20 to create a first path traveling around the pubicbone 105 and emerging in the opening 103 a formed in the anteriorvaginal wall 103;

[0119] d) using the puncturing needle 3 connected to an intermediatetraction means to create a second path around the pubic bone 105 andemerging in the opening 103 a formed in the anterior vaginal wall 103;

[0120] e) using cystoscopy to check that the making of these paths hasnot punctured the bladder 101 or the urethra 100;

[0121] f) connecting the parts of the device emerging from the opening103 a formed in the anterior vaginal wall 103;

[0122] g) pulling on the intermediate traction element 2 or 20 to adjustthe loop formed by the flexible means 1 on the underside of the urethra100;

[0123] h) separating and withdrawing the two halves of the sheath 5; and

[0124] i) leaving the tape 6 between the first suprapubic incision 106and the second suprapubic incision 107 passing under the underside ofthe urethra 100.

[0125] According to one embodiment of the invention, the methodcomprises guiding the paths of the puncturing needle 3 along theposterior surface 105 a of the pubis, by contact with the finger 50 ofthe surgeon introduced through the opening 103 a, formed in the anteriorvaginal wall 103, as far as the lower edge 105 b of the same side of thepubis 105.

[0126] In a variation, a one-piece needle may be used that can terminatein a male screw connecting piece. Passage of a track on the right andleft side is made by screwing a portion of the traction element to theproximal end of the needle. Cystoscopy verifies the absence ofpunctures; then the two tubular halves are connected to each other usingthe small metal part to form a single traction element disposed in aloop beneath the urethra. The remainder of the intervention isidentical.

[0127] According to one embodiment of the method according to theinvention, the flexible means 1 is attached to the intermediate element2 or 20 after the check provided for in step (e) has been made.

[0128] According to one embodiment of the method according to theinvention, the opening 103 a made in the anterior vaginal wall 103 isvertical.

[0129] According to a method of the invention, a urethral probe 60, forexample of the FOLEY balloon type, may be inserted into the patientbeforehand.

[0130] According to one embodiment of the treatment method according tothe invention, use is made of two intermediate traction elements 2 or 20connected end to end during step (f).

[0131] According to another embodiment of the treatment method accordingto the invention, the puncturing needle 3 and the intermediate tractionelement 2 or 20 are separated once the check according to step (e) hasbeen made and once the flexible means 1 has been introduced along thefirst path. This separation then makes it possible to create the secondpath using the puncturing needle 3 connected to the intermediatetraction element 2 or 20.

[0132] All of the above defined steps are now described with a deviceaccording to FIGS. 7 to 11 and the description relating thereto.

[0133] The first step (a) is illustrated in FIG. 12. The patient isplaced in a gynecological position and a sterile operating zone isformed. A urethral balloon probe 60 is positioned in the bladder 101 andis connected to a sterile collecting bag to empty and flatten thebladder 101. A short vertical incision 103 a, at most 30 mm long, ismade in the middle of the vaginal wall 103, for example in a T or Ishape, centered in the central third of the urethral canal 100 openingto the urinary meatus 100 a. Each lip 103 b of the vaginal incision 103a is detached from the underlying tissues using scissors 71 andappropriate instruments 70, as illustrated in FIG. 13.

[0134] Detachment is performed until the surgeon's index finger 50,introduced through the resulting opening 103 a, can reach the lower edge105 b of the pubis 105, away from the urethra 100 and the periurethraltissue (FIG. 14).

[0135] Next, a very small cutaneous incision 106, 107 less than 10 mmlong is made in the abdominal skin immediately above the pubis 105, oneach side of the centerline and about 20 mm away from the latter, toallow the percutaneous passage of the needle 3 just off the posteriorface 105 a of the pubis 30 in the direction of the vagina 104.

[0136] The surgeon's index finger 50 is introduced into the vaginalpassage thus prepared by detachment, and the active distal end 3 a ofthe needle 3 follows a path to come into direct contact with indexfinger 50. The path of the puncturing needle 3 is therefore controlled.The needle 3 can then reemerge through the vaginal opening 103 a and thebladder 101 has remained safe from any injury by the needle.

[0137] In general, the straight percutaneous path is made first. The endof the intermediate traction element, for example the tubular element20, reemerges behind the needle 3 via the vaginal opening 103 a. Thisend of the traction element 20 is for example unscrewed from theproximal end 3 b of the needle 3 and is detached from the latter in thedirection of the arrow S in FIG. 15.

[0138] The needle 3 is then passed along the second path (on theleft-hand side in FIG. 16) in the same way as for the first side(right-hand side). Once the distal part 3 a of the needle is well awayfrom the vaginal opening 103 a, it can be detached by unscrewing itsproximal portion 3 b. This separation is depicted diagrammatically bythe arrow T in FIG. 16.

[0139] The so-called proximal portion 3 b is long enough to project whenthe percutaneous incision 107 is made.

[0140] By way of an alternative form according to the invention, theproximal portion 3 b may be extended by an additional tubular element 20which projects out of the abdominal incision 107.

[0141] The next step consists in connecting the end of the tubulartraction element 20 that follows the first path to the proximal portion3 b or to the additional tubular element 20 that follows the secondpath.

[0142] Connection is made using the coupling 40 depicted in FIG. 17.

[0143] The proximal portion 3 b is then led back out through the abdomenby pulling in the direction of the arrow V illustrated in FIG. 18.

[0144] Before the flexible means 1 penetrates the patient's body, thetubular element 20 thus forms a loop around the urethra and its two endsreemerge respectively through the two abdominal cutaneous incisions 106and 107 (FIG. 18).

[0145] The urethral probe 60 may then be removed and cystoscopy is usedto check for the absence of vesical perforation.

[0146] Once the check has been made, the end of the tubular element 20that emerges from the abdominal incision 106 is assembled by screwfastening on the threaded end 30 a of the flexible means 1 (sheath 5plus tape 6) and the assembly is pulled (arrow V in FIG. 18) through theright and left paths to position the flexible means 1 under the urethra100. When this positioning which corresponds to step (g) is complete,the ends 1 a, 1 b of the flexible means 1 reemerge from the abdominalincisions 106, 107 as depicted in FIG. 21.

[0147] The sheath 5 may then be separated from the tape 6 by cutting thesheath 5 in its central zone 1 c and withdrawing each of the halves 51and 52 thus obtained through the corresponding abdominal incision 106,107 according to step (h) (arrows W in FIG. 19).

[0148] The tape 6 may thus be released, positioned and adjusted underthe underside of the urethra 100, usually in a central position, withouttension and without being squashed, as depicted in FIG. 20.

[0149] Once the sheath 5 has been withdrawn through each abdominalincision 106 and 107, the parts of the tape 6 which project out of theincisions 106 and 107 are cut off flush with the abdominal wall, theparts being left at the subcutaneous site.

[0150] The cutaneous incisions may be closed up using conventionalmethods.

[0151] The tape 6 advantageously runs around the pubic bone 105 via itspelvic or deep face, and heads towards the contralateral abdominal wall.

[0152] The resulting vaginal incision 103 a made in the vaginal wall 103may then be closed once the definitive position of the tape 6 under theurethra 100 has been checked.

[0153] By way of a variation, the traction lace 2 can also be used forimplementing the method.

[0154] The operating procedure thus used is notable in that it is apercutaneous operating technique because the dimension of the abdominalcutaneous incisions is minimal, intended to be just enough to allow theneedles to pass through and because the paths taken by the needle 3 aredownwards, in other words entering through abdominal incisions 106 and107 to emerge through the predetermined and prepared correspondingvaginal opening 103 a.

[0155] This presents an enormous advantage from the safety point of viewwith respect to the risks of puncturing the bladder 101 on the one hand,and the iliac vessels on the other hand.

[0156] This is a considerable advantage over the known operatingtechnique. The path can be checked by cystoscopy.

[0157] When it becomes apparent that the path is not appropriate, it ispossible to withdraw the intermediate traction element 2 or 20 to make asecond path through the abdominal cutaneous incision 106, and to do sowithout introducing the flexible means 1 into the body.

[0158] All of the elements of the device according to the invention canthus be reused if the manipulation is incorrect, or if the path insidethe patient's body needs to be improved or optimized. This represents aconsiderable advantage over the state of the prior art.

[0159] Furthermore, the surgical technique described requires neitherthe use of an insertion tool for the needle, nor the use of anendovesical rod to move the bladder 101 and the urethra 100 away eachtime the needle 3 passes on a downward path. This constitutes anadvantageous simplification insofar as the surgical technique putforward in the state of the art entails the use of an endovesical rodtwice, namely after each passage of each of the two needles which aremaking an upward path.

[0160] It is to be noted that the device according to the invention is apercutaneous device, which is advantageous when compared with the knowndevice which enters via the vaginal mucosa and emerges through the skinin the abdominal suprapubic region.

[0161] It is notable that the extreme simplicity of the device accordingto the invention contributes not only to reducing its cost price and thenumber of its constituent parts but also to increasing the safety forthe patient and the quality of the result when the operating techniquedescribed in the present invention is implemented.

[0162] Checking the effect obtained on continence and adjusting thetension of the tape 6 are not justified for two main reasons.Specifically, continence in a lying-down position is not comparable tothe upright position, and the effectiveness of the tape is explained notby a gripping effect (which carries the risk of leading to stenosis) butby an effect of providing uplifting support.

[0163] Furthermore, the operator chooses the position of the tape 6 withrespect to the urethral duct 100 according to the clinical case beingstudied.

[0164] In the state of the art, this choice cannot be made, andcontinence tests are carried out after the bladder has been filled andcoughing stress applied in order to adjust the tension in the tape, eventhough the technique is supposedly said to be “tension free”.

What is claimed is:
 1. A device for treating urinary stress incontinencein women, comprising: a flexible and elongate mechanism comprising atape for supporting a urethra and a flat protective sheath envelopingsaid tape; and a puncturing needle with an active distal end and aproximal end connected to a first end of the flexible and elongatemechanism, wherein the proximal end of the puncturing needle isconnected to a first end of the flexible and elongate mechanism by anintermediate traction element, a second end of the flexible and elongatemechanism being free.
 2. The device of claim 1, wherein the free secondend of the flexible and elongate mechanism is attached to an extended byan additional intermediate traction element.
 3. The device of claim 1,wherein the tape has a first end and a second end and wherein theprotective sheath completely envelopes the tape, including said firstand second ends of the tape.
 4. The device of claim 1, wherein thesheath is capable of being split into two parts that are separable bysliding them in opposite directions relative to the tape, and whereinsaid device comprises a splinable mechanism between central and adjacentends of the sheath.
 5. The device of claim 1, wherein the sheath iscapable of being split into two parts that are separable by sliding themin opposite directions relative to the tape, and wherein said devicecomprises a filament arranged roughly at right angles to a longitudinalaxis of the sheath, wherein said filament is configured to cut saidsheath when traction is exerted on said filament.
 6. The device of claim1, wherein the sheath comprises a fluoropolymer-based heat-shrinkablematerial.
 7. The device of claim 1, wherein the tape comprises amacroporous knitted material.
 8. The device of claim 1, wherein acentral region of the tape has a resorbable hydrophilic film thatreduces the risk of adhesion to or the risk of erosion of the urethra.9. The device of claim 1, wherein the puncturing needle has a curvedpart adjacent to a roughly straight part that ends at the proximal endof the puncturing needle.
 10. The device of claim 1, wherein theintermediate traction element is a traction lace.
 11. The device ofclaim 9, wherein said device further comprises an end piece onto whichthe sheath is heat shrunk and to which the traction lace attaches. 12.The device of claim 9, wherein the traction lace has a length roughlyequal to the length of the flexible and elongate mechanism.
 13. Thedevice of claim 1, wherein the intermediate traction element is atubular traction element.
 14. The device of claim 12, wherein thetubular traction element and the puncturing needle are attached byscrewing them together.
 15. The device of claim 12, wherein the tubulartraction element comprises two parts of roughly equal length, placed endto end and joined together removably.
 16. The device of claim 15,wherein said two parts of roughly equal length are joined together byscrewing them together using a coupling.
 17. The device of claim 1,wherein the puncturing needle with an active distal end and a proximalend connected to a first end of the flexible and elongate mechanism isthe only puncturing needle present in the device.
 18. The device ofclaim 1, wherein the tape comprises an open knit made up of two layersformed by two threaded guide bars each, one full guide and one emptyguide, the two threaded guide bars being movable symmetrically for anopen mesh.
 19. A method for treating urinary stress incontinence in awoman suffering from urinary stress incontinence, said methodcomprising: (a) forming an opening in an anterior vaginal wall; (b)creating, from two small suprapubic incisions formed in the abdominalwall, a right track and a left track from the abdominal skin to theopening formed in the anterior vaginal wall; (c) using a needle and anintermediate traction element to follow one of the tracks and followingthe other track with at least a needle; (d) verifying by cystoscopy thatthe paths of the tracks are outside the bladder and the urethra; (e)using a support tape surrounded by a plastic sheath to follow the tracksby passage under an inferior surface of the urethra; (f) adjusting aloop formed by the sheathed tape under the inferior surface of theurethra; (g) removing the sheath by pulling the sheath toward theoutside of the woman's body through the small suprapubic incisions; and(h) leaving the tape implanted from the first to the second incision andaround the urethra to support the urethra.
 20. The method of claim 19,wherein a needle and an intermediate traction element are used to followone of the tracks, and a needle and a second intermediate tractionelement are used to follow the other track.
 21. The method of claim 19,wherein each track is produced using a needle inserted through asuprapubic incision and guided along a posterior surface of a pubis incontact with a finger of a surgeon and introduced through an opening toa lower rim of the pubis on the same side as the suprapubic incisionthrough which the needle was inserted.
 22. The method of claim 19,wherein a distal end of the tape is connected to a proximal end of theintermediate traction element after verifying by cystoscopy.
 23. Themethod of claim 19, wherein the sheath is cut in a central region. 24.The method of claim 19, wherein the incision in the anterior vaginalwall is T or I shaped.
 25. The method of claim 19, in which vaginaldetachment is performed.
 26. The method of claim 19, in which a urethralprobe is inserted prior to performing a first incision.